Feasibility of a Mind-Body Program for Chronic Pain: A Randomized Clinical Trial

Abstract

Importance: Increasing physical function for individuals in chronic pain is challenging. Despite the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials guidelines, no pain trial has comprehensively assessed multimodal physical function (ie, self-reported, performance-based, and objective or step count-based measures), and most of these trials have limited racial and ethnic diversity.

Objective: To test the feasibility of a mind-body walking program and a health education program among geographically, racially, and ethnically diverse sedentary adults with chronic pain.

Design, setting, and participants: This single-blind, 2-arm, feasibility randomized clinical trial was conducted at Massachusetts General Hospital in the Northeast, Duke University in the Southeast, and Rush University in the Midwest, capturing a racially, ethnically, and geographically diverse US population. Recruitment occurred between April 2023 and January 2024. Participants were sedentary adults with chronic musculoskeletal pain. After baseline assessment, participants were randomized to either the mind-body walking program or the health education program. Given the pilot nature of this trial, all analyses were conducted on the observed data rather than following intent-to-treat principles.

Interventions: Both interventions consisted of 10 weekly hour-long, in-person group sessions.

Main outcomes and measures: Primary outcomes were feasibility benchmarks, including feasibility of recruitment, treatment arms, assessments, participant retention, racial and ethnic diversity attainment, treatment expectancy, treatment credibility, participant satisfaction, and treatment fidelity.

Results: Ninety-two participants were randomized to the mind-body walking program (n = 47) or the health education program (n = 45). Participants had a mean (SD) age of 57 (14.3) years; were predominantly females (69 [75.0%]); and included Asian (2.2%), Black or African American (44.6%), Hispanic (5.4%), non-Hispanic (83.7%), and White (40.2%) individuals. Both mind-body walking and health education interventions met the benchmarks for feasibility of treatment arms (95.7% [44 of 46 patients] and 82.2% [37 of 45 patients]), treatment credibility (100% (41 of 41 patients] and 87.2% [34 of 39 patients]), treatment fidelity (9.93 and 9.95 scores), assessment (93.0% accuracy), and participant retention (93.6% [44 of 47 patients] and 86.7% [39 of 45 patients]). Benchmarks for treatment expectancy (85.7% [36 of 42 patients] vs 66.7% [26 of 39 patients]) and participant satisfaction (97.6% [41 of 42 patients] vs 75.0% [30 of 40 patients]) were met in the mind-body walking program but not in the health education program. The racial and ethnic diversity benchmark was met (54.3% [50 of 92] vs ≥38.0% planned). The recruitment benchmark was not met (69.7% [92 of 132] of eligible participants recruited vs ≥80.0% planned).

Conclusions and relevance: In this trial, both a mind-body walking program and a health education program were feasible at 3 geographically, racially, and ethnically diverse academic medical centers. The findings support and inform a fully powered, multisite, future efficacy trial of these interventions.

Trial registration: ClinicalTrials.gov Identifier: NCT05700383.

Figure.. Participant Flow

Flowchart of participants’ disposition throughout the study.